(90 days)
The Zimmer Zfx Titanium Abutment for Straumann Bone Level Implant System is designed for use as a terminal or intermediate abutment for cement retained prostheses. The abutment can be used with Straumann Bone Level implants with a Narrow CrossFit Connection (NC) Ø3.3mm or Regular Crossfit Connection (RC) Ø4.1mm or Ø4.8mm.
The Zimmer Zfx Titanium Abutment for the Straumann Bone Level implant system is designed for use with Straumann Bone Level implants to support single or multi tooth restorations. The abutment/implant interface is a conical connection with 4 grooves for insertion guidance.
The Zimmer Zfx Titanium Abutment for Straumann Bone Level Implant System is a patient specific dental implant abutment with a competitor compatible interface. The purpose of a Patient-Specific abutment is to satisfy customer needs that are otherwise difficult to meet with off-the-shelf abutments. They can be manufactured in multiple sizes, shapes, and angles within the limits established in this submission. They frequently incorporate the modifications typically done at a dental laboratory or "chair-side" by a dentist. Traditional methodologies require the customer (dentist/laboratory technician) to begin with a "stock" abutment and use manual subtractive techniques to remove material from this original "stock" design. However, a Patient-Specific abutment will incorporate these same modifications desired by the customer (dentist/laboratory technician) at the time of fabrication at the manufacturing facility.
The engineering drawings list ranges in areas (attributes) of the abutment that may be modified depending upon patient-specific needs.
The abutment is composed of Titanium alloy (Ti6Al4V), and secured to the implant with a separate Titanium alloy screw for retention.
The new abutment will be offered in Narrow CrossFit (NC) Ø 3.3mm and Regular CrossFit (RC) Ø 4.1mm or Ø 4.8mm implant connection sizes.
The provided document is a 510(k) Pre-Market Notification for a dental abutment, which focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific performance criteria through a study with a test set of data. Therefore, many of the requested elements for AI/machine learning device studies are not applicable to this document.
However, I can extract information related to the non-clinical testing performed to support the substantial equivalence claim.
Here's the breakdown based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly define acceptance criteria in a quantitative table format for performance metrics like accuracy, sensitivity, or specificity, as would be expected for an AI/ML device. Instead, "acceptance criteria" are implied by demonstrating compatibility and equivalent mechanical performance to a predicate device through non-clinical testing.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compatibility | • The Zimmer Zfx Titanium Abutment for Straumann Bone Level Implant System can be deemed compatible with the Straumann Bone Level implant interface. |
| • Achieved through reverse engineering of Straumann Bone Level implants, abutments, and retaining screws. | |
| • Dimensional specifications were developed based on reverse engineering results. | |
| • Tolerance analysis and rotational analysis conducted to illustrate the nature of fit between Zimmer parts and OEM implant. | |
| Mechanical Strength/Fatigue | • Fatigue testing completed on Zimmer fabricated abutments assembled to OEM implants, in accordance with FDA guidance "Class II Special Controls Guidance Document: Root-form Dental Implants and Endosseous Dental Implant Abutments." |
| • Results were "compared to fatigue testing data of the predicate #3 device" (Straumann Bone Level Anatomic Abutment). The direct quantitative results of this comparison are not provided, but the conclusion is that the device is substantially equivalent. | |
| Sterilization | • Sterilization procedures listed in the Instruction For Use were validated to provide a minimum sterility assurance level of 10⁻⁶. |
| MRI Safety | • Evaluated for interactions with magnetic fields during MRI in accordance with FDA Guidance: "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment." |
| • Determined that the presence of the abutment poses no additional restrictions on MRI beyond what would otherwise occur for the patient. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: The document does not specify a "test set" in the context of an AI/ML study, but for non-clinical testing:
- Reverse Engineering: Based on "actual measurements taken from Straumann Bone Level implants, abutments and retaining screws." The exact number of units measured is not specified.
- Fatigue Testing: The number of Zimmer fabricated abutments and OEM implants used for fatigue testing is not specified.
- Data Provenance: The data is internally generated from non-clinical laboratory testing performed by Zimmer Dental Inc. (USA) and references FDA guidance documents. This is prospective data collection for the purpose of regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not an AI/ML study involving human expert ground truth for classification or diagnosis. The "ground truth" for compatibility and mechanical performance was established through engineering analysis and physical testing against established standards and predicate device performance.
4. Adjudication method for the test set
Not applicable. No expert adjudication method was employed as it was not an AI/ML study requiring human interpretation or consensus for a "test set."
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a medical device submission for a physical dental abutment, not an AI/ML software. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical dental abutment, not an algorithm.
7. The type of ground truth used
For the non-clinical testing:
- Compatibility: "Ground truth" was established by reverse engineering measurements of existing, legally marketed Straumann Bone Level implant components and developing dimensional specifications, and by conducting tolerance and rotational analyses to ensure proper fit.
- Mechanical Fatigue: "Ground truth" was established by comparing the fatigue test results of the new device to the fatigue testing data of the predicate device (#3, Straumann Bone Level Anatomic Abutment), as well as adherence to FDA guidance standards for dental implant abutments.
- Sterilization: Validation against a minimum sterility assurance level (SAL) of 10⁻⁶, a recognized standard.
- MRI Safety: Adherence to FDA guidance for assessing passive implants in an MR environment.
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set for an AI/ML model.
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Zimmer Dental 1900 Aston Avenue Carlsbad, CA 92008 760.929.4300 (ph) 760.431.7811 (fax)
Traditional 510(k) PRE-MARKET NOTIFICATION 510(k)
510(k) SUMMARY (21CFR807.92(a))
1 . Submitter's Information:
| Name: | Zimmer Dental Inc. |
|---|---|
| Address: | 1900 Aston Ave. |
| Carlsbad, CA 92008 | |
| Phone: | 760-929-4300 |
| Contact: | Julie Lamothe |
| Date Prepared: | April 28, 2014 |
-
- Device Name: Trade Name:
Regulation Number: Classification Code: Device Classification Name: Zimmer Zfx Titanium Abutment for Straumann Bone Level Implant System 872.3630 NHA Abutment, Implant, Dental, Endosseous
- Device Name: Trade Name:
-
- Predicate Device(s):
Predicate Device No. 1 Trade Name:
- Predicate Device(s):
510(k) Number: Regulation Number: Classification Code: Device Classification Name:
Predicate Device No. 2 Trade Name: 510(k) Number: Regulation Number: Classification Code: Device Classification Name:
Predicate Device No. 3 Trade Name: 510(k) Number: Regulation Number: Classification Code: Device Classification Name:
Zimmer Zfx Abutment for NobelReplace Implant System K120873 872.3630 NHA Abutment, Implant, Dental, Endosseous
Straumann Cares Abutment, Titanium K072151 and K081005 872.3630 NHA Abutment, Implant, Dental, Endosseous
Straumann Bone Level Anatomic Abutment K071357 872.3630 NHA Abutment, Implant, Dental, Endosseous
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4. Device Description:
The Zimmer Zfx Titanium Abutment for the Straumann Bone Level implant system is designed for use with Straumann Bone Level implants to support single or multi tooth restorations. The abutment/implant interface is a conical connection with 4 grooves for insertion guidance.
The Zimmer Zfx Titanium Abutment for Straumann Bone Level Implant System is a patient specific dental implant abutment with a competitor compatible interface. The purpose of a Patient-Specific abutment is to satisfy customer needs that are otherwise difficult to meet with off-the-shelf abutments. They can be manufactured in multiple sizes, shapes, and angles within the limits established in this submission. They frequently incorporate the modifications typically done at a dental laboratory or "chair-side" by a dentist. Traditional methodologies require the customer (dentist/laboratory technician) to begin with a "stock" abutment and use manual subtractive techniques to remove material from this original "stock" design. However, a Patient-Specific abutment will incorporate these same modifications desired by the customer (dentist/laboratory technician) at the time of fabrication at the manufacturing facility.
The engineering drawings list ranges in areas (attributes) of the abutment that may be modified depending upon patient-specific needs.
The abutment is composed of Titanium alloy (Ti6Al4V), and secured to the implant with a separate Titanium alloy screw for retention.
The new abutment will be offered in Narrow CrossFit (NC) Ø 3.3mm and Regular CrossFit (RC) Ø 4.1mm or Ø 4.8mm implant connection sizes.
.5. Indications for Use:
The Zimmer Zfx Titanium Abutment for Straumann Bone Level Implant System is designed for use as a terminal or intermediate abutment for cement retained prostheses. The abutment can be used with Straumann Bone Level implants with a Narrow Crossfit Connection (NC) Ø 3.3mm or a Regular Crossfit Connection (RC) Ø 4.1mm or Ø 4.8mm.
6. Device Comparison:
The new abutment device is substantially equivalent to the predicates relative to material, manufacturing process and general design features. It is fabricated from Titanium alloy and utilizes a conical connection implant/abutment interface with 4 grooves for insertion guidance, which is identical in size and
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shape (for a given platform diameter) to the predicate device. The new abutment and base device will be affixed to the implant by a retaining screw, the same manner as the predicate.
7. Technological Characteristics
| Feature | New Device | Predicate #1 | Predicate #2 | Predicate #3 |
|---|---|---|---|---|
| Zimmer Zfx TitaniumAbutment for StraumannBone Level ImplantSystem | Zimmer Zfx Abutmentfor NobelReplaceImplant System | Straumann CaresAbutment, Titanium | Straumann Bone LevelAnatomic Abutment | |
| Material | Titanium 6Al-4V | Titanium 6Al-4V | Titanium | Titanium |
| ImplantInterface | Conical Connectionwith 4 grooves | Internal Tri-lobe | Conical Connection with4 grooves | Conical Connection with4 grooves |
| Emergence | Contoured, curved | Contoured, curved | Contoured, curved | Contoured, curved |
| Margin | Pre-machined | Pre-machined | Pre-machined | Pre-machined |
| PlatformDiameter | 3.3 (NC), 4.1/4.8 (RC) | 3.5mm, 4.3mm,5.0mm, 6.0mm | 3.3 (NC), 4.1/4.8 (RC) | 3.3 (NC), 4.1/4.8 (RC) |
| Cuff Width | 2.8mm-8mm (NC)3.3mm-10.0mm (RC) | 3.5mm-12.0mm | 10mm MAX (NC)13mm MAX (RC) | 4.0mm (NC)6.5mm (RC) |
| Cone Angle | 0-30° | 0-20° | 0-30° | 30° |
| MinimumHeight | 3.0mm MIN Cone3.0mm-12.0mm Overall | 3.0- 11.5mm Cone3.5-12.0mm Overall | 17mm MAX Overall | 5.5mm Cone7.5mm and 9.0mm overall |
| RetainingScrew | New device | ZFX09000642 | Cat No. 025.2900 and025.4900 | Cat No. 025.2900 and025.4900 |
8. Non-Clinical Testing:
Non-clinical test data was used to support the decision of substantial equivalence. This consisted of reverse engineering, compatibility analysis and mechanical fatigue testing. The Straumann Bone Level interface was reverse engineered based on actual measurements taken from Straumann Bone Level implants, abutments and retaining screws in order to assure that the Zimmer Zfx Titanium Abutment is compatible with Straumann Bone Level Implant Systems. Dimensional specifications were developed for the Zimmer fabricated components based on the reverse engineering results. A tolerance analysis as well as a rotational analysis was conducted to illustrate the nature of fit between the Zimmer fabricated parts and the OEM implant. To verify the compatibility of the Zimmer device to the OEM device, fatigue testing was completed using Zimmer fabricated abutments assembled to OEM implants in accordance with the FDA guidance Class II Special Controls Guidance Document: Root-form Dental Implants and Endosseous Dental Implant Abutments. The results were compared to fatigue testing data of the predicate #3 device. Based on the reverse
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engineering process, as well as verification of the final connection dimensions and tolerances, the Zimmer Zfx Titanium Abutment for Straumann Bone Level Implant System can be deemed compatible with the Straumann Bone Level implant interface.
The Zimmer Zfx Titanium Abutment for the Straumann Bone Level Implant System will be sold non-sterile and will be sterilized by the end user. The sterilization procedures listed in the Instruction For Use were validated to provide a minimum sterility assurance level of 10°.
Additionally, Zimmer Dental implant systems were evaluated for interactions with magnetic fields during Magnetic Resonance Imaging (MRI) in accordance with the FDA Guidance: Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment. This was done to determine that the presence of the abutment poses no additional restrictions on MRI beyond those that would otherwise occur for the patient.
ல் Clinical Testing
No clinical testing was performed. Non-clinical testing was used to support the decision of safety and effectiveness.
10. Conclusion
Based on our analysis, the device is substantially equivalent to the predicate.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-00002
July 29, 2014
Zimmer Dental. Inc. Julie Lamothe, Ph.D Regulatory Affairs Manager 1900 Aston Ave. Carlsbad. CA 92008-7308
Re: K141120
Trade/Device Name: Zimmer Zfx Titanium Abutment for Straumann Bone Level Implant System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: April 21, 2014 Received: April 30, 2014
Dear Dr. Lamothe:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to Mav 28. 1976. the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH docs not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21. Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Dr. Lamothe
Please be advised that FDA 's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office
of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Mary S. Runner -
S
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
K141120 510(k) Number (if known):
Device Name: Zimmer Zfx Titanium Abutment for Straumann Bone Level Implant System
Indications For Use:
The Zimmer Zfx Titanium Abutment for Straumann Bone Level Implant System is designed for use as a terminal or intermediate abutment for cement retained prostheses. The abutment can be used with Straumann Bone Level implants with a Narrow CrossFit Connection (NC) Ø3.3mm or Regular Crossfit Connection (RC) Ø4.1mm or Ø4.8mm.
× Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sheena A. Green -S 2014.07.28 09:29:17 -04'00'
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)